Use of corrective infant helmet

ABSTRACT

A method and apparatus for treating infant plagiocephaly whereby a helmet encircles the upper cranium of an infant and prevents the infant from resting its head on flattened or depressed regions of the skull. The helmet contemplates an adjustable first member which encircles the infant&#39;s upper cranium, and a second member comprising a relatively rigid protruding element that is attached to the exterior surface of the first member. The second member is positioned so that it is superincumbant to flattened or depressed regions, so that when the helmet is worn, the second member forces the infant to rest its head on a different area of the skull, thus passively relieving pressure on the depressed skull, and applying a gentle active pressure to other areas. Additionally, the method an apparatus relates to the treatment of torticollis and other abnormalities of the neck.

FIELD OF THE INVENTION

[0001] The present invention relates to orthopedics, particularly tocorrecting abnormal head shape in infants, and to the treatment oftorticollis.

BACKGROUND

[0002] The cranium of a human infant is made up of frontal, parietal,temporal, occipital and other smaller bones that are separated bymembranous intervals until brain growth is complete at eighteen totwenty-four months of age. Normally, the infant cranium is symmetricalin shape. However, in the condition known as plagiocephaly, the head isnon-symmetrical, becoming parallelogram or rhomboid shaped. Sometimesthe plagiocephalic head may correct its shape over time, but often thecondition may persist, leading to facial asymmetry with functional,cosmetic, and other disabilities. If orthotic treatment is indicated, itis important to attempt correction of the deformation when the subjectis less than a year old, before the sutures in the cranium havesolidified.

[0003] The shape of the infant cranium is determined by multiple factorsincluding brain growth and development, constraints placed on the skullduring and after gestation and bony abnormalities of the skull. When aninfant's head is maintained in a nearly fixed position either in uteroor when sleeping on a flat surface, the cranium may be progressivelydeformed. A condition known as occipital positional plagiocephaly ordeformational plagiocephaly frequently occurs in children who sleep in arelatively constant position on their backs. For example, as a result ofthe American College of Pediatrics recommendation that children beplaced on their back instead of on their stomach to avoid SIDS (SuddenInfant Death Syndrome), a significant number of new cranial deformitiesare being seen (Argenta, L. C., et al., J. Craniofac. Surg. 7:5-11(1996)). In addition, many infants have craniums that are deformedeither in utero or during the birth process, and sleeping on thedepressed portion of the skull accentuates the deformity. Infants whoare slower to develop motor activity may also develop cranialabnormalities because of their failure to move their heads frequently.Finally, in some cases plagiocephaly is secondary to synostosis, acondition in which some of the skull sutures fuse too soon, making theskull bulge somewhere else.

[0004] Unfortunately, surgery is often the treatment prescribed tocorrect plagiocephaly of the infant skull. While plagiocephaly secondaryto synostosis usually requires surgery, many deformities of the skullcan be corrected with appropriate molding helmets (Argenta, L. C., etal., J. Craniofac. Surg. 7:5-11 (1996); Claren, S. K., et al., J.Pediatrics 94:43-46 (1979)). Such helmets take advantage of thepliability of the infant skull to mold the skull into a normal shape.

[0005] There are basically two types of corrective infant helmets. Anactive helmet is a device that places an active constricting force onthe skull to force it to grow in a more normal fashion. These helmetsare marketed as Dynamic Orthoplast Cranioplasty (DOC) helmets. Ingeneral, active DOC helmets must be custom fitted, require greateramounts of time for fabrication, and must be changed frequently as theinfant head increases in size. As a result, DOC helmet therapy requiresmultiple clinic visits and may cost in the range of several thousands ofdollars per patient. In addition, placing a constricting force on thegrowing brain is not thought to be physiological by most physicians.

[0006] Passive helmets or soft shell helmets attempt to take pressureoff of the deformed portion of the skull, thus allowing the brain togrow in a more normal fashion. Thus, in contrast to active molding,passive helmets provide for a more gradual and physiological correctionof skull shape.

[0007] A graded series of sized helmets for treatment of infantplagiocephaly were described in U.S. Pat. No. 4,776,324 to Claren. TheClaren helmet is generated based on horizontal and transverse imagingmeasurements of either a patient skull or the skull of a normal infant.The Claren helmet fully encloses the head, and is designed such that itis slightly larger than the patient's skull. The helmet uses passivemolding in that the head grows into the helmet. A graded series ofprefabricated helmets are required as an alternative to the previoustechnology using individualized helmets shaped to each patient's skull.

[0008] Although full helmets are effective in treating plagiocephaly(Argenta, L. C., et al., J. Craniofac. Surg. 7:5-11 (1996)), they areconfining and uncomfortable. Additionally, the use of several helmets iscumbersome and it can be difficult to match the individual patient'sskull with the prefabricated helmets available. Alternatively, thehelmets which are generated based upon the patient's individualizedskull shape are expensive and time consuming to produce.

[0009] A cranial remodeling band using active molding to treatplagiocephaly is described in U.S. Pat. No. 5,094,229 to Pomatto.Pomatto described a cranial remodeling band with an internal surfacewhich reflects the desired reconfiguration of the subject's cranium. Thetechnology employs active molding, in that it applies corrective forcesto those regions of the cranium which protrude. The technology isexpensive, however, in that effective therapy requires that the orthosisbe individualized for each subject, and a series of helmets is requiredfor each infant.

[0010] A helmet to correct brachycephalic cranial abnormalities isdescribed in U.S. Pat. No. 5,308,312 to Pomatto. The brachycephalic headis expressed as an occipital flattening of the cranium such that themaximal cranial breadth is disproportionately large in relation to themaximum cranial length. The helmet described in U.S. Pat. No. 5,308,312is designed to address a unique form of abnormal head shape. However,the helmet has many of the disadvantages of other helmets, e.g., formaximum effectiveness, the helmet must be fabricated from an impressionof the individual subject's head.

[0011] Thus, there is a need to develop corrective infant helmets thatprovide a gentle but effective therapy for the large majority ofplagiocephalic infants. Rather than squeezing unaffected regions of theinfant brain, it would be preferable to relieve the pressure fromdepressed areas of the skull. To enable correction of the abnormalitybefore the brain plates begin to fuse, a helmet must be comfortableenough to be worn for the extended periods of time, up to 23 hours aday. In addition, such therapeutic helmets should be affordable andaccessible to the many patients who require treatment.

SUMMARY OF THE INVENTION

[0012] The invention provides a helmet which, when worn by an infant,provides for a gentle reshaping of an infant's skull. The helmet is aband to which a rounded, external protrusion is attached. By positioningthe protrusion directly above an area on an infant's head which isabnormally flat, the helmet encourages the infant to roll away from theflattened area, and to rest its head on a different region of the skull.The result is that pressure on the flat area of the skull is reduced,and pressure due to the weight of the infant's head is directedelsewhere. Also, by providing a means for active positioning of theinfant's head, the helmet provides a means for treating neckabnormalities such as torticollis.

[0013] Thus, the invention provides in one aspect, a method andapparatus for treating plagiocephalic abnormalities of the infantcranium. The invention contemplates a helmet, which when worn by aninfant with a plagiocephalic skull, forces the infant to turn his headaway from a depressed portion of the skull and to lay upon regions ofthe head which protrude. In contrast to previous therapeutic methods,the disclosed invention employs both passive and active molding in thatit passively relieves pressure from depressed areas of the skull whileactively increasing pressure on areas of the skull which are distended.

[0014] The helmet comprises a pre-fabricated, adjustable first memberthat fits around an infant's head, leaving a substantial portion of thepatient's upper cranium and ears exposed. In a preferred embodiment thefirst member comprises two discontinuous sections which overlap eachother. The circumference of the first member may be adjusted by slidingthe two sections of the first member together or apart. In addition, thefirst member is punctuated with apertures which provide ventilation, andif required, can be adapted for affixing fasteners. The first membershould be strong enough to protect the infant's head, but comfortable towear. Thus, in a preferred embodiment, the exterior of the helmetcomprises a high impact plastic and the interior of the helmet is linedwith foam padding.

[0015] A substantially rigid convex second member is attached to theexterior of the first member and positioned directly above the depressedregion on the infant's skull. The second member is shaped so that whenthe infant rests it head upon a flat surface, the infant's head rollsoff of the second member and comes to rest on a different region of theskull. By adjusting the size and shape of the second member,abnormalities of varying size, shape and location may be selectivelytreated.

[0016] In another aspect, the invention relates to a method for thetreatment of torticollis. Placing the second member on the same side ofthe head as those neck muscles which are affected forces the head to theside away from the torticollis. As the affected muscles become stretchedand more relaxed, the second member can be progressively increased insize.

[0017] The foregoing focuses on the more important features of theinvention in order that the detailed description which follows may bebetter understood and in order that the present contribution to the artmay be better appreciated. There are, of course, additional features ofthe invention which will be described hereinafter and which will formthe subject matter of the claims appended hereto. It is to be understoodthat the invention is not limited in its application to the details ofconstruction and to the arrangement of the components set forth in thefollowing description and drawings. The invention is capable of otherembodiments and of being practiced or carried out in various ways.

[0018] From the foregoing summary, it is apparent that an object of thepresent invention is to provide a new and improved apparatus and methodfor the treatment of infant head and neck abnormalities. These, togetherwith other objects of the present invention, along with the variousfeatures of novelty which characterize the invention, are pointed outwith particularity in the claims annexed to and forming a part of thisdocument.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019]FIG. 1 is a perspective view of an infant wearing the correctivehelmet of the invention while lying against a sleeping surface.

[0020]FIG. 2 is a top view of the corrective helmet.

[0021]FIG. 3 is a side view of the helmet showing overlap of theanterior and posterior sections of the first member and attachment ofthe second member.

[0022]FIG. 4 is a partial side view of the posterior section of thefirst member and its attachment to the second member.

DETAILED DESCRIPTION OF THE INVENTION

[0023] According to one aspect of the present invention, an apparatusand a method for treating plagiocephaly and other types of deformationalcranial asymmetry in the infant skull comprises an adjustable firstmember to which is attached a substantially rigid protruding secondmember, where the first member encircles the cranium of an infant andthe second member is positioned above a depressed area on the infant'scranium.

[0024] In one embodiment of the invention, the first member encirclessubstantial areas of the infant's occipital and frontal cranial regions.More preferably, the first member is shaped to provide openings for theinfant's cephalad-most cranium and ears. Even more preferably, the firstmember is comprised of a first section and a discontinuous secondsection, with guides by which the first and second sections may beoverlapped and secured in position relative to one another. The guidespreferably comprise oblong-shaped apertures. More preferably, the twosections of the first member are secured relative to one another bymeans of fasteners which are attached to one of the sections andinserted through guides on the other section. Most preferably, onesection of the first member encircles the anterior portion of theinfant's cranium and the second section encircles the posterior portionof the infant's cranium. This allows the overlapping segments to bepositioned over the infant's ears. The use of an overlapping segmentenables the helmet to be decreased or enlarged in size by sliding thetwo sections of the first member together or apart, respectively. Thus,when initially placed on the infant's head, the helmet is adjusted tofit, and the anterior and posterior bands are positioned by securingfasteners positioned in the overlapping segment. The ability to adjustthe size of the helmet minimizes the need for a series of helmets andallows the helmet to accommodate the infant's head as it grows.

[0025] The first member should be strong enough to protect the infant'shead, but flexible enough for long-term wear. In a preferred embodimentthe first member comprises an exterior surface of high impact plastic.Most preferably, the first member comprises an exterior surface ofpolyethylene. Alternatively, the first member comprises an exteriorsurface of lightweight metal. More preferably, the first membercomprises an exterior surface of aluminum alloy. In another preferredembodiment, the first member comprises an exterior surface selected fromthe group consisting of polycarbonate, polyethylene, polypropylene,polyamide, polyurethane, cellular plastic, graphite, fiberglass,aluminum, aluminum alloy and titanium.

[0026] The interior of the first member comprises foam padding. Mostpreferably, the interior of the first member comprises open cellpolyurethane. In another preferred embodiment, the interior of the firstmember comprises a material selected from the group consisting ofStyrofoam, open cell polyurethane, closed cell polyethylene, and rubber.Alternatively, the interior of the first member comprises an inflatablebladder. If necessary, additional internal padding may be used to enablefitting the helmet an infant whose skull is severely deformed.

[0027] A detachable protruding second member is attached to the exteriorof the first member and positioned superincumbent to a depressed regionon the infant's skull. The protruding second member is a shape such thatwhen the infant rests its head against a flat surface, the protrudingsecond member will encourage the infant's head to roll away from thedepressed area, and to lie on a different region of the skull. In apreferred embodiment, the second member is substantially convexcurvilinear in shape. Most preferably, the second member comprises aconvex band. In another preferred embodiment, the second membercomprises a shape selected from the group consisting of a hemisphere, atruncated cone, a trapezoid, and an inverted cup. In another preferredembodiment the second member comprises multiple components that arepositioned on the first member to generate a generally hemisphericalprotrusion. The use of multiple components allows increased variation inthe precise shape and size of the protrusion. In yet another preferredembodiment, the second member comprises an inflatable bladder.

[0028] The second member may be increased or decreased in size so as todiscourage the infant, to varying degrees, from resting on the flatportion of the skull, depending on the severity of the deformity. Alarger protrusion would more strongly tend to force the head to theopposite side, whereas a smaller protrusion would simply encourage thehead to roll off the affected area. In infants with bilateraldeformities, the bump can be applied centrally, thus preventing theinfant from lying directly on the central portion of the back of theskull and forcing the head to either side so that corrective growth canoccur.

[0029] In a preferred embodiment, the first member comprises aperturesadapted for affixing fasteners. More preferably, these apertures arepositioned at intervals along the first member. The ability to attachfasteners at specified intervals along the first member provides a meansby which the second member can be positioned above a depressed region ofthe infant's skull. Thus, in a preferred embodiment, the second member,or individual sections of the second member, comprise one or moreapertures adapted to accommodate fasteners affixed along the firstmember. More preferably, when the second member is a convex band, theapertures comprise U-shaped slots at the ends of the band. By insertingfasteners affixed at intervals along the first member into apertures inthe second member, the second member is secured at various positionsalong the first member. Additionally, multiple apertures on the firstmember may be provided to increase ventilation and reduce the overallweight of the helmet.

[0030] To increase flexibility in positioning the second member, amethod of attaching the second member which is independent of theplacement of fasteners on the first member is employed. Thus, in apreferred embodiment, attachment of the second member to the firstmember comprises a non-invasive method, and more preferably the methodis selected from the group comprising adhesive, snaps, VELCRO, andthermal molding.

[0031] To force the infant's head away from the underlying depressedregion of the skull, the second member should be made of substantiallyrigid material. This prevents the second member from flexing, therebypreventing the infant from resting its head directly on the secondmember. Thus, in a preferred embodiment the second member comprises highimpact plastic. Most preferably, the second member comprisespolyethylene. In another preferred embodiment the second membercomprises metal. More preferably, the second member comprises aluminumalloy. In another preferred embodiment, the second member comprises amaterial selected from the group consisting of polycarbonate,polyethylene, polypropylene, polyurethane, polyamide, cellular plastic,rubber, graphite, fiberglass, aluminum, aluminum alloy, and titanium.

[0032] Finally, because the helmet is based on passively relievingpressure on the depressed regions, it does not have to be custom fittedto the infant's skull. Generally, the helmet is adjusted to fit snuglyon the infant's head, so that space between helmet and the protrudingregion(s) on the infant's skull is minimized. However, to secure thehelmet in position so that the protruding second member remains over thedepressed region of the infant's skull, the helmet is preferably securedon to the infant's head by a detachable chin strap.

[0033] In a second aspect of the invention, a method is provided for thetreatment of torticollis. Torticollis is a condition in which themuscles of one portion of the neck are excessively tight. Usually theinfant favors the affected side of the neck. This results in the headbeing twisted to one side, which can produce a secondary depression andasymmetry of the skull. Such children require frequent exercises tomobilize the head to the opposite side. The use of a corrective helmetwith an appropriate protruding element forces the head to the side awayfrom the torticollis. Progressive increases in size of the protrudingelement are employed as the neck muscles become increasingly relaxed.

[0034] Thus, a typical helmet is constructed of a polyethylene firstmember approximately 2-4 mm thick and molded to fit on the head of anormal 6 month old infant. The upper opening measures 14 cm across theanterior to posterior axis of the helmet, and 11 cm across the width ofthe helmet, while the lower opening measures 16.5 cm along the anteriorto posterior axis and 13 cm from ear to ear. The first member is formedas two discontinuous sections which overlap as rounded flaps above, andjust posterior to, the ears. Oval-shaped guides present on the anteriorsection of the first member are used to secure both sections relative toone another. These guides are apertures which typically measure on theorder of 0.5 cm in width and 2.5 cm in length, and the overlap issecured in place with conventional screws. For comfort, the first memberis punctuated with circular apertures 1 cm in diameter which are spacedapproximately 2.5 cm apart in a parallelogram pattern. These aperturesprovide ventilation, and additionally, may be used to position fastenersto attach the second member anywhere along the helmet. Finally, VELCROstrips are glued to the first member to enable attachment of a VELCROchin strap.

[0035] The second member may be of any shape such that when the infantrests its head upon the second member, the head is encouraged to roll toa different area of the skull. Typically, the second member will beformed of polyethylene and is shaped as a convex band. The band measures16.5 cm by 5 cm, and is shaped so that it protrudes from the firstmember by a radial distance of about 3-6 cm. The second member ispositioned above a depressed region on the infant's skull by insertingfasteners attached to the first member through aperture(s) on the secondmember. For a second member shaped as a convex band, the apertures aretypically U-shaped slots positioned at the end of the band, and the bandis secured to the first member using conventional screws.

[0036] Referring to FIG. 1, the helmet of this invention takes the formof a first member 12 which is shaped to encircle the frontal 14,temporal 16 and occipital 18 bone regions of the cranium. The helmetleaves a significant part of the infant's head exposed, including thecephalad most cranium 20 and the ears 22. The first member 12 comprisesa first section 24 and a second section 26, which are joined at anoverlapping section 28. The use of a discontinuous first member enablesthe helmet size to be increased or decreased to fit around the infant'shead. On the back half of the helmet is a detachable protruding secondmember 30. The second member 30 is positioned on the first member 12 sothat the second member 30 is directly overlying a depressed portion ofthe patient's skull 32. The second member 30 forces the head to lie sothat another area of the skull is apposed against a mattress, thusrelieving pressure on the depressed side of the skull 32 and applyingpassive force to a region of the skull which is proportionatelydistended. A strip of VELCRO 38 is glued to first section 24 to enablethe addition of a chin strap for securing first member 12 on theinfant's head.

[0037] Referring to FIG. 2, the helmet is positioned on the infant'shead so that second member 30 overlies a depressed portion of theinfant's skull 32. For maximum comfort, the top of the infant's head 20is exposed. The outer layer 50 of the first member 12 is made of a highimpact, light weight material, such as polyethylene. The inner surfaceof the first member 12 may be lined with a soft cushion 52 such aspolyurethane. The first section 24 of the first member 12 whichencircles the front of the head 54, and the second section 26 of thefirst member 12 which encircles the back of the head 56, are fitted suchthat there is an overlapping section 28. In this mode, the two sections24 and 26 of the first member 12 can slide towards each other to tightenthe helmet, or away from each other to loosen the helmet (see FIG. 3).

[0038] Referring to FIG. 3, fasteners 60 attached to second section 26are inserted through guides 62 on first section 24 to stabilize theposition of first section 24 and second section 26 relative to eachother. The fasteners 60 are then tightened to secure the first member 12as one continuous unit. Similarly, second member 30 is connected to thesecond section 26 of first member 12 by fasteners 64 which pass throughU-shaped apertures 66 located on the ends 70 of second member 30. Boththe second section 26 and the first section 24 of first member 12 arepunctuated by apertures 68 to facilitate positioning second member 30along the helmet. Additional apertures 72 may be added to facilitatecooling of the infant's head, and reduce the overall weight of thehelmet.

[0039] Referring to FIG. 4, second member 30 is connected to secondsection 26 of first member 12 by fasteners 64 which pass throughU-shaped apertures 66 positioned on the ends 70 of second member 30.Fasteners 64 are then secured in apertures 68 in first member 12. In apreferred embodiment, apertures 68 adapted for affixing second member 30may be structurally identical to, and therefore co-functional with,apertures 72 adapted for ventilation.

[0040] Generally, the benefits of the helmet include a gentle therapyfor the treatment of skull abnormalities. The helmet does not squeezethe patient's head, but simply forces the infant to sleep on thenon-depressed region of the skull. Except for preventing the infant fromlying on the affected area, the helmet allows for universal movement ofthe head. Because the helmet is open at the top, it is cooler than theavailable passive helmets which fully enclose the head, allowing forcomfortable wear for extended periods. Because the helmet is adjustableand does not require molding to the individual patient head, iteliminates the cost of custom fittings and custom fabrications. In caseswhere the patient skull is severely deformed, extra foam padding may beplaced inside the helmet to facilitate fit.

EXAMPLE

[0041] The helmet of the invention is manufactured essentially asfollows. To fashion the exterior shell of the first member, two flat,rectangular pieces of plastic are shaped to conform to the overalloutline of the first and second sections of the first member,respectively. Both sections of the shell are then molded using atemplate which has been generated based upon measurements taken from aseries of normal infant skulls or CAT skans. After both sections of theshell have hardened into their final shape, padding is glued to theinternal surface of each section. The padding does not extend the entirelength of each section, but leaves those areas included in the region ofoverlap uncovered. Multiple apertures are then drilled through both theinterior and the exterior of the first member. These apertures areevenly spaced along both sections of the first member. Also,oblong-shaped guide apertures are cut in the overlapping region on oneof the sections. Fasteners are then glued onto the external surface, orthreaded through the apertures on the first member. Also, VELCRO stripsare affixed to the exterior of the helmet to enable the use of a chinstrap. The first member is then assembled, leaving fasteners insertedthrough guides in the overlapping region loose enough to be readjusted.

[0042] The template for producing the first member may be produced fromany durable material such as wood, plastic or metal. To accommodatechanges in the patient's skull size, first members are prefabricated inseveral sizes such that the resultant helmets encompass the majority ofskulls for infants 3 months to 2 years of age. Because infants' skullsfollow a bell shaped growth curve, a relatively well-defined and narrowrange of helmets will overlap the majority of infant head sizes. Customhelmets can be made for exceptional skulls.

[0043] Similarly, a second member shaped as a convex band may beproduced by molding the central section of a flat band of plastic arounda cylindrical template to produce a convex band. In most cases, a seriesof three or more bands of increasing convexity are sufficient. Thus, forsevere deformities a larger, or more convex, protrusion would be used,while for milder deformities, a smaller protrusion would be used.Alternatively, a substantially hemispherical-shaped mold may be used formaking a second member comprised of multiple components. The overallshape of a second member comprised of multiple components may beincreased by spacing individual components of the second member furtherapart, or by using sections which are larger, or more convex, in shape.

[0044] With respect to the descriptions set forth above, optimumdimensional relationship of parts of the invention (to includevariations in size, materials, shape, form, function and manner ofoperation, assembly and use) are deemed readily apparent and obvious tothose skilled in the art, and all equivalent relationships to thoseillustrated in the drawings and described in the specification areintended to be encompassed herein. The foregoing is considered asillustrative only of the principal of the invention. Since numerousmodifications and changes will readily occur to those skilled in theart, it is not intended to limit the invention to the exact constructionand operation shown and described, and all suitable modifications andequivalents falling within the scope of the appended claims are deemedwithin the present inventive concept.

[0045] It is to be further understood that the phraseology andterminology employed herein are for the purpose of description and arenot to be regarded as limiting. Those skilled in the art will appreciatethat the conception on which this disclosure is based may readily beused as a basis for designing the structures, methods and systems forcarrying out the several purposes of the present invention. The claimsare regarded as including such equivalent constructions so long as theydo not depart from the spirit and scope of the present invention.

What is claimed is:
 1. A cranial passive remodeling orthosis comprising:a first member for encircling the cranium of an infant which comprisesan exterior surface and an interior surface, and at least oneoverlapping segment permitting said member to be enlarged or decreasedin circumference; and a substantially rigid second member affixed to andprotruding from said exterior surface of said first member.
 2. Theorthosis of claim 1, wherein said first member encircles substantialareas of said infant's occipital and frontal cranial regions.
 3. Theorthosis of claim 1, wherein said first member comprises at least oneopening for said infant's cephalad-most cranium.
 4. The orthosis ofclaim 1, wherein said first member comprises openings for said infant'sears.
 5. The orthosis of claim 1, wherein said first member furthercomprises a first section and a second section.
 6. The orthosis of claim5, wherein said first section of said first member overlaps said secondsection of said first member.
 7. The orthosis of claim 6, wherein saidfirst section of said first member comprises guides which position saidfirst section of said first member relative to said second section ofsaid first member.
 8. The orthosis of claim 7 wherein said guidescomprise oblong-shaped apertures.
 9. The orthosis of claim 8, whereinfasteners inserted through said guides on said first section of saidfirst member are affixed to said second section of said first memberthereby securing said first section and said second section in a stableposition relative to one another.
 10. The orthosis of claim 9, whereinsaid first section of said first member is further characterized asencircling the anterior portion of said infant's cranium and said secondsection of said first member is further characterized as encircling theposterior of said infant's cranium.
 11. The orthosis of claim 1, whereinsaid exterior surface of said first member comprises high impactplastic.
 12. The orthosis of claim 1, wherein said exterior surface ofsaid first member comprises metal.
 13. The orthosis of claim 1, whereinsaid exterior surface of said first member comprises a material selectedfrom the group consisting of polycarbonate, polyethylene, polypropylene,polyamide, cellular plastic, graphite, fiberglass, aluminum, aluminumalloy, and titanium.
 14. The orthosis of claim 1, wherein said interiorsurface of said first member comprises foam padding.
 15. The orthosis ofclaim 1, wherein said interior surface of said first member comprises aninflatable bladder.
 16. The orthosis of claim 1, wherein said interiorsurface of said member is selected from the group consisting ofStyrofoam, open cell polyurethane foam, closed cell polyethylene foam,and rubber.
 17. The orthosis of claim 1, wherein said first membercomprises one or more apertures adapted for affixing fasteners to saidfirst member.
 18. The orthosis of claim 17, wherein said one or moreapertures are positioned at intervals along said first member.
 19. Theorthosis of claim 1, wherein said first member comprises one or moreapertures adapted to ventilate said infant's cranium.
 20. The orthosisof claim 1, wherein said second member comprises a convex curvilinearprotrusion.
 21. The orthosis of claim 20, wherein said second membercomprises a convex shape selected from the group consisting of ahemisphere, a truncated cone, a trapezoid, and an inverted cup.
 22. Theorthosis of claim 1, wherein said second member comprises one or moreapertures adapted to accommodate fasteners affixed to said first member.23. The orthosis of claim 22, wherein fasteners affixed to said firstmember are inserted through said apertures on said second member. 24.The orthosis of claim 1, wherein said second member comprises a convexband.
 25. The orthosis of claim 24, wherein said apertures on saidsecond member comprise at least one U-shaped slot located at each end ofsaid band.
 26. The orthosis of claim 1, wherein said second membercomprises multiple sections.
 27. The orthosis of claim 26, wherein saidmultiple sections of said second member as positioned on said firstmember comprise a substantially hemispherical protrusion.
 28. Theorthosis of claim 1, wherein said second member comprises an inflatablebladder.
 29. The orthosis of claim 1, wherein said second membercomprises non-invasive attachment to said first member.
 30. The orthosisof claim 29, wherein said non-invasive attachment comprises a methodselected from the group consisting of adhesive, snaps, VELCRO, andthermal molding.
 31. The orthosis of claim 1, wherein said second membercomprises high impact plastic.
 32. The orthosis of claim 1, wherein saidsecond member comprises metal.
 33. The orthosis of claim 1, wherein saidsecond member is a material selected from the group consisting ofpolycarbonate, polyethylene, polypropylene, polyurethane, polyamide,cellular plastic, rubber, graphite, fiberglass, aluminum, aluminumalloy, and titanium.
 34. The orthosis of claim 1, wherein said firstmember is held in position on said infant's head by a chin strap.
 35. Amethod for treating infants with skull shape abnormalities comprisingthe steps of: fashioning a first member which comprises an exteriorsurface and an interior surface to substantially encircle the cranium ofan infant, attaching to said exterior surface of said first member asecond member made of substantially rigid material, and positioning saidfirst member around said infant's head such that said second member issuperincumbant to a region on said infant's skull which is depressedrelative to neighboring regions.
 36. A method for treating patients withtorticollis comprising the steps of: fashioning a first member whichcomprises an exterior surface and an interior surface to substantiallyencircle the cranium of an infant, attaching to said exterior surface ofsaid first member a second member made of substantially rigid material,and positioning said first member around said infant's head such thatsaid second member is overlying a region on said infant's skull which isopposite to that region of the neck muscles affected.